Setting the bar: Compliance with ovarian cancer quality indicators at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center (CCC)

Setting the bar: Compliance with ovarian cancer quality indicators at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center (CCC)

Abstracts / Gynecologic Oncology 137 (2015) 2–91 41 Survival analysis estimated median overall survival for stage IIIC with PDS as 42.7 months compa...

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Abstracts / Gynecologic Oncology 137 (2015) 2–91

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Survival analysis estimated median overall survival for stage IIIC with PDS as 42.7 months compared with NACT as 32.9 months (P b 0.001), but median survival was the same for stage IV disease (30.2 vs. 30.6 months). In multivariate analysis, patients who received NACT compared to PDS with stage IIIC disease had a slightly greater mortality risk (HR = 1.23), but the relative risk was less profound than age N71 years (1.64), comorbidities (1.62), grade 3 disease (1.70), CT alone (2.12), or surgery alone (1.64). Conclusions: Evidence suggests that patients with greater adverse risk factors are more likely to receive NACT than PDS. Although patients who receive NACT have a somewhat worse mortality compared to PDS, this may be a reflection of older, medically infirm patients with advanced disease rather than an inherently inferior treatment option. doi:10.1016/j.ygyno.2015.01.094

93 — Featured Poster Session Surgical complexity score and oncologic outcomes following optimal or complete cytoreductive surgery for ovarian, fallopian tube and primary peritoneal cancers L.S. Krilla, A. Nickles Faderb, E.J. TannerIIIb, M. Gerardi Fairbairnc, R.E. Bristowd. aUniversity of California Irvine Medical Center, Orange, CA, USA, b Johns Hopkins Medical Institutions, Baltimore, MD, USA, cJohns Hopkins Medical Institutions, Columbia, MD, USA, dUniversity of California, Irvine, Irvine, CA, USA Objectives: Appropriate surgical candidate selection and maximum surgical effort are critical to the management of advanced ovarian cancer. This study sought to determine what effect surgical complexity has on postoperative morbidity, disease recurrence, and survival following primary or interval cytoreductive surgery for the treatment of advanced ovarian cancer. Methods: A single-institution retrospective review identified all patients undergoing optimal (b1 cm) or complete (no gross residual disease [NGRD]) cytoreduction during primary or interval debulking for stage III and IV ovarian, fallopian tube, or peritoneal cancers between 1/95 and 12/08. Surgical, postoperative, and survival data were extracted from the medical record. Surgical complexity scores (SCSs) were calculated based on the number and relative difficulty of the procedures performed.⁎ The primary endpoints were progression-free survival (PFS) and overall survival (OS). Fisher's exact test, Kaplan–Meier survival analysis, and multivariate Cox proportional hazards regression were used. Results: Two hundred ninety-seven cases were analyzed. On univariate analysis, high SCS was associated with complete cytoreduction but also more major complications (P b 0.05). Kaplan–Meier analysis indicated that neither PFS nor OS was significantly different between the simple vs. complex SCS risk categories (median PFS, 21.5 vs. 15.8 months, P = 0.18; median OS, 50.5 vs. 35.6 months, P = 0.26) (Fig. 1). Cox proportional hazards regression confirmed that high SCS did not independently predict OS (HR 1.42; 95% CI 0.98–2.06), despite superior PFS (HR 1.50; 95% CI 1.07–2.10). Stage IV disease, age N75 years, American Society of Anesthesiologists score N3, and major complications were associated with worse OS. The absence of visible residual disease was the only covariate associated with improved PFS (HR 0.73; 95% CI 0.56–0.94) and OS (HR 0.73; 95% CI 0.55–0.97). Conclusions: Quality care for advanced ovarian cancer should include any necessary procedures to minimize the amount of residual carcinoma remaining after initial debulking surgery. After controlling for NGRD, survival is equivalent regardless of how this benchmark is achieved (i.e., low or high SCS). The increased risk of short-term morbidity with high SCS is likely justified by the survival advantage conferred by reaching NGRD for many patients. SCS calculated based on previously published point-scale used to quantify the extent of surgical complexity developed at the Mayo Clinic.

Fig. 1. Kaplan-Meier Survival curves for overall survival (main outcome effects) stratified

Aletti GD, Dowdy SC, Podratz KC, Cliby WA. Relationship among surgical complexity, short-term morbidity, and overall survival in primary surgery for advanced ovarian cancer. American journal of obstetrics and gynecology 2007;197:676 e1-7. doi:10.1016/j.ygyno.2015.01.095

94 — Featured Poster Session Setting the bar: Compliance with ovarian cancer quality indicators at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center (CCC) M.I. Lianga, A.C. ElNaggarb, S. Nekkantia, D.M. O'Malleyb, E.M. Hadec, L.J. Copelandb, J.M. Fowlerb, R. Salanib, F.J. Backesb, D.E. Cohnb. aThe Ohio State University, Columbus, OH, USA, bThe Ohio State University, James Cancer Hospital, Columbus, OH, USA, cThe Ohio State University Medical Center, Columbus, OH, USA Objectives: Quality measures are being developed for ovarian cancer and will be tracked to improve health care delivery and determine payment processes. Our objective was to evaluate compliance at a National Cancer Institute-designated comprehensive cancer center (CCC) with eight ovarian quality indicators proposed by the Society of Gynecologic Oncology (Table 1). Methods: A total of 123 patients underwent primary staging or cytoreductive surgery and adjuvant chemotherapy for invasive ovarian cancer from 2010 to 2012 at a single CCC. Patients were excluded if they received any treatment at another institution. Descriptive statistics were performed to determine compliance. Results: Quality indicator (QI) #1: A total of 121/123 (98.4%) patients had an operative report documenting residual disease dictated within 48 h of cytoreduction. QI #2: Complete surgical staging was performed in 25/55 (45.5%) patients with stage I–IIIB disease. Peritoneal biopsies and bilateral pelvic and bilateral paraaortic lymphadenectomy were each omitted in about one third of patients. QI #3 & 4: In patients with optimally debulked stage III disease, 52/56 (92.9%) were offered intraperitoneal (IP) chemotherapy, with 29/56 (51.8%) receiving IP and 19 of these within 42 days. Most patients who did not receive IP were due to comorbidities or randomization in a clinical trial. QI #5: All 105 patients for whom adjuvant chemotherapy was indicated received platin or taxane and 79/105 (75.2%) within 42 days. QI #6: Venous thromboembolism prophylaxis was provided in 122/123 (99.2%) patients by mechanical

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Abstracts / Gynecologic Oncology 137 (2015) 2–91

means and 98/123 (79.7%) by pharmacologic means within 24 h of surgery. QI #7 & 8: A total of 119/121 (98.3%) patients received prophylactic parenteral antibiotics within 60 min of cytoreduction and these were discontinued in 120/121 (99.2%) cases. Conclusions: These data can help establish benchmark criteria for integrating ovarian indicators into actual practice. The surprisingly low percentage of “completely staged” patients deserves additional exploration as to whether this is a flaw in reporting or a lack of compliance. The study not only identifies areas for improvement but also demonstrates the importance of documentation when medical reasons prevent indicators from being met. Further validation requires prospective evaluation of these indicators and their correlation to patient outcomes, such as survival. Table 1 SGO ovarian indicators 1. Operative report with documentation of residual disease within 48 h of cytoreduction for women with invasive ovarian, fallopian tube, or peritoneal cancer 2. Complete staging for women with invasive stage I–IIIB ovarian, fallopian tube, or peritoneal cancer who have undergone cytoreduction 3. Intraperitoneal chemotherapy offered within 42 days of optimal cytoreduction to women with invasive stage III ovarian, fallopian tube, or peritoneal cancer 4. Intraperitoneal chemotherapy administered within 42 days of optimal cytoreduction to women with invasive stage III ovarian, fallopian tube, or peritoneal cancer 5. Platin or taxane administered within 42 days following cytoreduction to women with invasive stage I (grade 3), IC–IV ovarian, fallopian tube, or peritoneal cancer 6. Venous thromboembolism prophylaxis administered within 24 h of cytoreduction to women with invasive ovarian, fallopian tube, or peritoneal cancer (NQF Endorsed #0218) 7. Order for prophylactic parenteral antibiotic administration within 1–2 h before cytoreduction for women with invasive ovarian, fallopian tube, or peritoneal cancer (NQF Endorsed #0527) 8. Order for prophylactic parenteral antibiotic discontinuation within 24 h after cytoreduction for women with invasive ovarian, fallopian tube, or peritoneal cancer (NQF Endorsed #0529)

doi:10.1016/j.ygyno.2015.01.096

95 — Featured Poster Session The use of NCCN guideline therapy in the first line/adjuvant setting in patients with ovarian cancer from 6 NCCN institutions D.M. O'Malleya, J. Nilandb, M.A. Bookmanc, R.A. Burgerd, M. Cristeab, J. Griggse, G.M. Mantia-Smaldonef, L.A. Meyerg, C.C.L. Sung, A. Wrighth, D.E. Cohna. aThe Ohio State University, James Cancer Hospital, Columbus, OH, USA, bCity of Hope, Duarte, CA, USA, cUniversity of Arizona Cancer Center, Tucson, AZ, USA, dUniversity of Pennsylvania, Philadelphia, PA, USA, eUniversity of Michigan Health Systems, Ann Arbor, MI, USA, fFox Chase Cancer Center, Philadelphia, PA, USA, gThe University of Texas MD Anderson Cancer Center, Houston, TX, USA, h Brigham and Women's Hospital/Dana Farber Cancer Institute, Boston, MA, USA Objectives: Adherence to National Comprehensive Cancer Network (NCCN) guidelines for treatment of ovarian cancer (OC) is associated with improved survival, but only 37% of patients received NCCN guideline-adherent care in one recent study. Our aim was to examine the proportion of patients who received guideline-concordant adjuvant (adj) chemotherapy (chemo) to treat both early- and late-stage OC. Methods: This prospective cohort study involved 1364 women with stage I–IV OC treated at six NCCN institutions between 2003 and 2012. Concordance was defined by receipt of adj chemo per NCCN guidelines (Gynecologic Oncology Group [GOG] 172, intravenous (IV) platinum and taxane) or a clinical trial with high-risk early-stage (HR-ES) disease or advanced disease (ADV) within 90 days of diagnosis and avoidance

of chemo in patients with low-risk, early-stage (LR-ES) disease. Trends were evaluated in 1098 ADV, 201 HR-ES, and 65 LR-ES patients. Results: In ADV, 77% (64%–87%) of patients received guidelineconcordant care with a level 1 evidence-based chemo regimen or research protocol and 64% completed at least 6 cycles. Of the 251 nonconcordant patients, the most common reason for nonconcordance was no therapy within 90 days (25%). The most common alternative regimens were modifications of the GOG 172 intraperitoneal/IV regimen (36%). Single-agent carbo was given to 11% of the population, and another 5% did not receive a platinum and taxane. In early-stage disease, 78% (63%–88%) initiated the recommended or research based therapy within 90 days and completed at least 3 cycles. Conversely, nonconcordant chemo was received in 23% (10%–33%) of patients with stage IA/IB, grade 1 disease. Conclusions: At NCCN institutions, adherence to treatment recommendations for adj chemo was 77% in patients with ADV disease, 78% in those with HR-ES disease, and 77% in those with in LR-ES disease. Use of guideline-concordant chemo was nearly double what has been reported previously, but there is still room for improvement because nearly 20% of patients were either undertreated or overtreated at NCCN institutions. doi:10.1016/j.ygyno.2015.01.097

96 — Featured Poster Session Impact of time interval from definitive surgery to initiation of adjuvant chemotherapy (ISC) on survival for advanced epithelial ovarian cancer Y.Y. Leea, E.J. Heoa, A. Yoona, G. Yoonb, C.H. Choia, T.J. Kimc, J.W. Leec, M.K. Kimd, D.S. Baec, B.G. Kimc. aSamsung Medical Center, Seoul, South Korea, bSungkyunkwan University School of Medicine, Seoul, South Korea, cSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, dSungkyunkwan University School of Medicine, Changwon-Si, South Korea Objectives: We investigated the prognostic impact of the interval from surgery to initiation of adjuvant chemotherapy (ISC) in advanced epithelial ovarian cancer. Methods: We enrolled patients with advanced epithelial ovarian cancer (FIGO stages III and IV) who were treated at Samsung Medical Center from January 1, 2001 to December 31, 2010. We excluded patients who received neoadjuvant chemotherapy. Results: A total of 507 patients (stage III: 448; stage IV: 59) were enrolled, and the median ISC was 9 days, with a range of 4 to 84 days. We divided the patients into three groups: no gross residual group (n = 109, 21.5%), optimal group (n = 206, 40.6%), and suboptimal group (n = 192, 37.9%). Delayed ISC was associated with increased HRs for overall survival only in the optimal group. In subsequent analyses performed in the optimal group, we found ISC to be a continuous variable (HR, 1.016; 95% CI, 1.005–1.031; P = 0.007). History of consultation by the department of general surgery (HR, 2.744; 95% CI, 1.345–5.599; P = 0.006) and platinum resistance (HR, 7.175; 95% CI, 4.112–12.52; P = 0.007) were significantly associated with poor overall survival. On multivariate analysis, ISC remained a significant poor prognostic factor (HR, 1.018; 95% CI, 1.003–1.033; P = 0.022). The cutoff value of HR significantly increased on the 17th day of ISC (HR, 2.744; 95% CI, 1.345–5.599; P = 0.006) in the multivariate analysis. Conclusions: Based on the collected data, delayed adjuvant chemotherapy subsequent to surgery most likely would result in a negative impact on overall survival in advanced epithelial ovarian cancer patients who have optimal cytoreduction. doi:10.1016/j.ygyno.2015.01.098